The present invention relates to a cryogenic container that is suitable in particular for storing and/or transporting a medium. The cryogenic container is, in particular, suitable for storing and/or transporting a biochemical and/or medical product. The present invention further relates to a secondary container, for use in a cryogenic container according to the invention, and to a preparation device for storage of a medium. The invention further relates to a method for storing and/or transporting a medium, in particular once again a biochemical product. Such devices and methods can be used in particular in the production and/or supply of pharmaceutical and/or diagnostic products which are generally in liquid form particularly at room temperature, but which are generally frozen for storage and/or transport.
In the production and/or supply of media, in particular media with active substances for diagnostics and/or medical therapy, i.e. in particular medical products and/or pharmaceuticals, suitable handling of the media presents a technical challenge. In many cases, in the pharmaceutical production of, for example, biotechnical materials, the media are frozen for storage and/or transport. Cryogenic vessels, also referred to as cryo vessels, are generally used for the freezing and subsequent thawing. These cryogenic containers are generally solid containers made of stainless steel and having a double casing. The product in the containers is frozen and/or thawed via a silicone oil circuit. However, the demands in respect of the sterility of cryogenic containers of this kind, especially for biotechnical materials, are very high.
A crucial disadvantage of the known technology in this area is that, after the container has finished being used, cleaning and sterilization are needed. This is very time-consuming and expensive. It can also happen that silicone oil escapes at the coupling points where silicone oil is supplied to the silicone oil circuit. In addition, large storage surfaces are required, which entail high capital expenditure. The flexibility needed to meet varying requirements is generally not afforded.
These requirements in respect of sterility generally necessitate that the cryogenic containers are operated in circulation, which entails enormous outlay in terms of transport and storage. In particular, the cryogenic containers, which have a considerable weight (in some cases several hundred kilograms), and which have a large volume of in some cases several cubic meters, have to be kept in storage and transported.
In addition to these reusable cryogenic containers, devices are also known from the prior art in which the medium is introduced into a disposable bag and frozen in the latter. U.S. Pat. No. 7,104,074 and EP 1 441 585 B1, for example, disclose containers for freezing, storing and thawing biopharmaceutical materials, which containers can be received in a supporting frame. In these film containers, the biopharmaceutical material is frozen by means of contact heat transfer to a heat transfer surface.
A disadvantage of this prior art, however, is that containers of this kind have to be designed with comparatively thin walls in order to permit rapid freezing of the biopharmaceutical materials without phase separation. At the same time, however, containers of this kind with thin walls are extremely sensitive to mechanical damage, and therefore, in some cases, it is not possible to ensure that the containers are transported safely, without damage and in a sterile condition. Moreover, complex transport and storage devices are needed to ensure the materials being stored and transported in the frozen state.